Revofer 500 mg/10 ml (IV Injection or Infusion)
10 ml vial: ৳ 700.00
Medicine Details
Category | Details |
---|---|
Generic | Ferric carboxymaltose |
Company | Square pharmaceuticals plc |
Also available as |
Indications
- Treatment of iron deficiency anaemia in adult patients
- Intolerance to oral iron
- Non-dialysis dependent chronic kidney disease
Description
- Colloidal iron (III) hydroxide in complex with Carboxymaltose
- Carbohydrate polymer that releases iron
Dosage & Administration
- Stepwise approach
- Determination of individual iron need based on body weight and haemoglobin (Hb) level
- Calculation and administration of the iron dose(s)
- Post-iron repletion assessments
- Maximum individual iron dose(s) based on iron need
- Administration by intravenous injection or infusion
- Re-assessment by the clinician based on the individual patient's condition
- Re-assessment of Hb level no earlier than 4 weeks post final administration
Interaction
- No formal drug interaction studies performed
Contraindications
- Hypersensitivity to active substance or any excipients
- Serious hypersensitivity to other parenteral iron products
- Anaemia not attributed to iron deficiency
- Evidence of iron overload or disturbances in the utilisation of iron
Side Effects
- Infrequent, usually mild and generally do not cause patients to stop treatment
- Common: nausea, headache, dizziness, hypertension, injection site reactions
- Uncommon: hypersensitivity, tachycardia, hypotension, flushing, dyspnoea, abdominal pain, constipation, diarrhea, Pruritus, urticaria, rash, myalgia, back pain, arthralgia, muscle spasms
- Rare: anaphylactoid reactions, loss of consciousness, anxiety, phlebitis, syncope, bronchospasm, flatulence, angioedema, pallor, and face oedema, rigors, malaise, influenza like illness
Pregnancy & Lactation
- No adequate and well-controlled trials in pregnant women
- Benefit/risk evaluation required before use during pregnancy
- Unlikely risk to breast-fed child based on limited data
Precautions & Warnings
- Serious hypersensitivity reactions reported
- Monitoring for signs and symptoms of hypersensitivity during and after administration
- Hypertension: transient elevations in systolic blood pressure
- Laboratory Test Alterations: overestimation of serum iron and transferrin bound iron by also measuring the iron in Revofer
Use in Special Populations
- Single maximum daily injection dose of 200 mg iron not to be exceeded in haemodialysis-dependent chronic kidney disease patients
- Not recommended in children under 14 years
Overdose Effects
- Excessive dosages may lead to accumulation of iron in storage sites potentially leading to hemosiderosis
- Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation
Therapeutic Class
- Parenteral Iron Preparations
Storage Conditions
- Cool and dry place below 30°C
- Away from light
- Do not freeze
- Keep out of reach of children
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